efsa activities on environmental risk assessment (era) · 2020-04-03 · efsa activities on...

EFSA activities on environmental risk assessment (ERA)

Thematic discussion: Changing context for ERA

Senior Scientific Officer (Ecology)

Yann Devos, Domenica Auteri and Guilhem de Seze

75th Advisory Forum meeting

Virtual meeting, 1-2 April 2020

• EFSA’s ERA portfolio (snapshot)

• Changing context for ERA

• Collaborative initiatives

Today’s goals

EFSA’s ERA portfolio (snapshot)

Protection goals

Human healthAnimal healthAnimal welfare

Plant healthEnvironment

(biodiversity, ecosystems, ecosystem services, …)

…

Stressors (agricultural food/feed production)

Animal diseases (zoonotic/non-zoonotic)

Biological hazardsBotanicals

Chemical mixturesContact materials

ContaminantsDiet (food/feed)Emerging risks

Endocrine active substancesEnzymes

FlavouringsFeed additives (FA)

Genetically modified organisms (GMO)

NanomaterialsNovel foods/feeds

Plant protection products (PPP)(active substances)

Processing aidsQuarantine plant pests (QPP)

…

EFSA’s remitSimplified

Development of risk assessment tools and data

gathering

Assessment of post-market

environmental monitoring

(PMEM) reports

Development and revision of risk

assessment guidance (incl. cross-cutting

ones)

ERA of quarantine plant

pests

Assessment of pre-market

registration and market renewal

applications (incl. risk

mitigation and/or management measures)

ERA activitiesSnapshot

PPP

GMO

FA


gathering



(PMEM) reports



ones)

ERA of quarantine plant pests



applications (incl. risk mitigation

and/or management measures)


QPP: Citrus long-horn beetle

QPP: Apple snail


gathering



(PMEM) reports

Development and revision of risk assessment

guidance (incl. cross-cutting

ones)


pests



applications (incl. isk mitigation



Cross-cutting

•Protection goals

•Recovery

•Endangered species

•Nano-materials

•Synthetic biology

•Good modelling practices

PPP

•Plants

•Animals (bees, arthropods, reptiles, amphibians, birds, bats, mammals, aquatic organisms)

•Exposure assessment

GMO

•GM micro-organisms

•GM plants

•GM animals

•New genomic techniques

•Synthetic biology

•Gene drive

FA

•Feed additives

QPP

•Plant pests


gathering



(PMEM) reports



ones)


pests






GMO: GM plants for cultivation


gathering



(PMEM) reports



ones)


pests






Bio

logic

al RA Preparedness to risks of

new plant pests

Integrated spatial analysis for biological risk assessment

Wildlife surveillance

Building capacity for microbiome assessments C

hem

ical RA Risk assessment of

combined exposure to multiple chemicals; cumulative risk assessment

Introducing new approach methodologies (NAM) for hazard assessment and risk characterisation

Environm

enta

l RA MUST-B: Holistic approach

for the risk assessment of MUltiple STressors in Bees

Landscape-based ERA

Non-target Lepidoptera model

TK/TD models in aquatic environment

Data collection for endocrine disruption assessment for non-target organisms

Critical appraisal forms for ecotoxicological studies

Changing context for ERA

• Science• Scientific advances (incl. innovation)

• Deliver new tools, methods and data relevant for regulatory science

• Scientific analyses

• Scientific Advice Mechanism [SAM] (2018)

• EU authorisation processes of PPP – From a scientific point of view

• European Environment Agency [EEA] (2019)

• The European environment – State and outlook (2020)• “… alarming rate of biodiversity loss, increasing impacts of climate change and

the overconsumption of natural resources”

• Harvey et al. (2020) Nature Ecology & Evolution

• Roadmap for insect conservation and recovery

• Science (2020)

• A cleaner, greener future for chemicals

Drivers of changeExamples

• Wicked environmental problems• Environmental issues become increasingly complex

• Societal demands• Citizens of Europe demand more sustainable food systems

• Children strike over climate change

• EU policy context• Council conclusions “Towards a Sustainable Chemicals Policy Strategy”

• Common Agricultural Policy for 2021-2027

• Biodiversity Strategy for 2030

• New Green Deal

• Promote sustainable food through the new “Farm to Fork” strategy; Protect biodiversity; Strive to zero pollution; Act on climate change; Move to a circular economy

Drivers of changeExamples

Risk assessment science in regulatory context

Who mandates

EFSA (excl. self-

tasking)?

European Commission

European Parliament

EU Member States (other national food safety bodies)

• Regulatory frame

• EFSA 2027 Strategy development• Preliminary considerations on “Future of ERA”

• To be framed by new Green Deal goals and “Farm to Fork” strategy

Possible strategic goals for ERAOngoing activity/work in progress

Un

der

cu

rren

t secto

r-sp

ecif

ic r

eg

ula

tio

ns Consolidate & innovate

• By revising current methods

• By integrating new relevant tools, methods, data and expertise

• By sharing data

• By collaborating between relevant actors and key stakeholders A

cro

ss a

ll r

ele

van

t re

gu

lati

on

s Foster systems-based approaches & their interoperability

• By integrating

• Sector-specific ERAs across multiple stressors, across spatial and temporal scales, across policies and regulatory frames, and across regional, national and EU agencies

• Pre- and post-registration data (incl. environmental monitoring and surveillance data)

Possible avenues to advance ERAShort, medium and long term perspective

Ensure robust and up to date ERA methodologies

Integrate new tools, methods, data and expertise for landscape-scale population-level ERA

Develop and implement methodologies for cumulative and mixture risk assessments

Optimise the use of environmental monitoring and surveillance data

Make ERAs interoperable for all regulated stressors and with EU environmental impact and sustainability assessments

Ensure preparedness for the next generation of regulated stressors and application technologies

Consider impacts of (non-regulated) environmental drivers when framing ERA as part of the problem formulation process

Monitor new scientific tools, methods and data, and assess their relevance for ERA, and promote their implementation and integration

Create an EU collaborative platform for ERA (virtual centre of excellence)

Collaborative initiatives

• DG SANTE initiative on setting specific protection goals• ERA of PPP

• Series of workshops

• June 2019• National authorities

• September 2019• Stakeholders (farmer associations, applicants, academia, industry, retailers and non-

governmental organisations)

• February 2020• National authorities and stakeholders

• Between EU Member States• Tasking Grant Framework

• e.g. for PPP: EFSA-ANSES, EFSA-BfR and EFSA-BPI

Collaborative initiativesExamples

• Between EU Agencies• ECHA-EFSA

• Hazard identification of endocrine disruptors (PPP and biocides) [with technical support from JRC]

• ERA for bees (PPP and biocides)

• Impact of water treatments on residues of substances in water used as drinking water

• EEA-EFSA

• Identification of relevant climate change scenarios for CLEFSA project (climate change as driver of emerging risks for food/feed safety, plant and animal health, and nutritional quality)

• EMA-EFSA

• ERA of feed additives (i.e. coccidiostats)


• EU bee partnership discussion group• Trigger

• MEP request to ensure sustainable pollination and beekeeping in EU (at 2017 bee week event on data collection & sharing)

• Scope

• Bee health assessment (honeybees first and then other bees)

• Goals

• Improve data collection, management and sharing (harmonisation/standardisation)

• Develop tools for the assessment of bee health (holistic manner)

• Engage with stakeholders

• Partners

• Beekeeper associations, conservation organisations, farmer associations, plant protection and veterinary medicine industry, risk assessors, scientists and veterinarians


• Proposal for an EU collaborative platform on ERA• Main goals

• While building on existing regulatory frames and involving risk managers

• Facilitate cooperation on current and future ERA challenges/needs

• Bring all relevant actors and key stakeholders together

• Promote exchange of relevant ERA and monitoring data, knowledge and expertise

• Validate new tools and methods and promote their uptake in regulatory science;

• Bridge gaps in regulatory science

Create a virtual centre of excellence for regulatory science

Advance ERA and ensure preparedness


• Proposal for an EU collaborative platform on ERA• Scope

• Relevant actors (including risk managers) and key stakeholders

• Commission services

• EU agencies

• EU Member States (national authorities)

• Policy makers

• Scientists

• Non-governmental organisations

• Applicants

• Civil society

• Regulated stressors associated with agricultural food/feed production


• Proposal for an EU collaborative platform on ERA

• Plan

• 2020

• Outsource roadmap development• Incl. feasibility assessment

• 2021 and beyond

• Actions driven by roadmap outcomes


Take home messages

• ERA is in EFSA’s remit• Regulated products associated with agricultural food/feed production (i.e.

PPP, GMO, FA)

• QPP

• Changing context for ERA• New Green Deal and “Farm to Fork” strategy

• Possible avenues to advance ERA

• Proposal for an EU collaboration platform on ERA• Outsource roadmap development

Take home messages

• EFSA colleagues• EGSMOSE Mark

• IPPOLITO Alessio

• MAGGIORE Angelo

• NOUGADERE Alexandre

• PADOVANI Laura

• RIOLO Francesca

• RORTAIS Agnès

• SCHOONJANS Reinhilde

• SHARP Rachel

• STANCANELLI Giuseppe

• STREISSL Franz

• TARRES-CALL Jordi

• VETTORI Maria Vittori

• VOS Sybren

Thank YOU

Questions

If you wish to take the floor to speak, please indicate this

in the meeting chat by simply using the

wave emoji

Points for thematic discussion

1. Do you see added value in the establishment of an EU collaborative platform for ERA?

2. Do you see cooperation opportunities and challenges?

3. Are you aware of relevant existing collaborative partnerships and those that are under development?

4. Do you have suggestions for developing the roadmap for the creation of an EU collaborative platform on ERA?

Discussion points

efsa activities on environmental risk assessment (era) · 2020-04-03 · efsa activities on...

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